Spec 3, Clinical Research

About the role

This laboratory-based position will provide input to design, evaluation, execution and reporting for safety and efficacy of new or modified in-vitro diagnostic devices, as well as provide innovative ideas cross functionally with other business units. The role requires technical competence and works with human blood in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care and capable operation of numerous instrument platforms.

Responsibilities

• Manage clinical laboratory studies and complaint testing through a variety of clinical testing methods.
• Develop and implement new testing methodologies in collaboration with R&D.
• Understand product design, function and apply quality and regulatory standards.
• Utilize technical/scientific judgment to resolve technical issues.
• Work with multiple disciplines (manufacturing, marketing, quality, regulatory, etc.) to develop core and non-core clinical laboratory products and services.
• Provide input to and conduct scientific investigations in areas of considerable scope and complexity.
• Explore, identify and recommend solutions, concepts and principles; adapt methodologies as needed.
• Conduct clinical testing, maintain laboratory instrumentation/reagent test systems and inventory to align with lab and business priorities.
• Implement and document Quality Assurance and Quality Control procedures for instrumentation and methodology.
• Conduct instrument verification per CLSI guidelines; assist with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP.
• Stay current in the field of Clinical Laboratory Science through technical literature review, continuing education and customer visits.
• Train new associates on laboratory workflow.
• Monitor trends in laboratory practices and recommend new projects or influence ongoing ones.
• Participate in development of the clinical strategy for BD IDS-Specimen Management products and generate scientific and clinical information to support product development.
• Ensure scientific integrity and clinical accuracy of all claims and communications concerning specific PAS products globally.
• Manage individual focused projects to complex projects involving multiple internal clinical studies/evaluations.
• Resolve customer complaints through clinical investigations.
• Support innovation, product development, clinical testing, manufacturing and post-market surveillance via interfacing with R&D and GCD.

Knowledge and Skills

• Strong working knowledge of clinical laboratory science
• Excellent verbal and written communication skills
• Awareness/basic knowledge of GCP/GLP and ISO regulations
• Phlebotomy experience is a plus
• Experience with human blood specimen collection products
• Product troubleshooting as it relates to clinical results
• Strong computer skills
• Strong project planning and budget management skills
• Proven understanding of clinical laboratory testing, blood collection, urinalysis, point of care and ability to apply knowledge to innovative concepts/projects beyond the core clinical laboratory

Education and Experience

• BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology, Life Sciences or health-related field required
• MT/MLT CLS (ASCP) or equivalent experience in a research environment
• 5+ years of experience in a clinical laboratory environment